- The companies have completed the enrolment in P-II AKI-002-15 study evaluating the safety and efficacy of ANG-3777 (2.0 mg/kg, IV) vs PBO over 4 days in patients with CSA-AKI across the US, Canada, Brazil, and Georgia
- The first dose was given within 4hrs. of the completion of surgery with subsequent doses @24hrs. interval. The 1EP is an increased percentage of serum creatinine above baseline, starting from 24hrs. after the end of cardiopulmonary bypass surgery through day 6.
- The companies plan to initiate confirmatory trial early in 2022, following the results of P-II study as well as discussions with the FDA and other relevant health authorities. The topline data is expected in H2’21
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